Department of Ophthalmology, Faculty of Medicine, University of Coimbra (FMUC); Centro Hospitalar e Universitário de Coimbra (CHUC); Association for Innovation and Biomedical Research on Light and Image (AIBILI), Coimbra, Portugal

Michael Larsen

Department of Ophthalmology, Rigshospitalet and Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

Purpose :
To assess the efficacy and safety of ranibizumab 0.5 mg treat and extend (T&E) versus a monthly regimen in patients with neovascular age-related macular degeneration (nAMD) from the TREND study.

Methods :
TREND was a phase IIIb, visual acuity (VA) assessor-masked, multicenter, interventional, 12-month study (NCT01948830). Treatment-naïve patients aged ≥50 years (N=650) were randomized (1:1) to receive ranibizumab T&E (n=323) or monthly (n=327). Patients on the T&E regimen received 2 initial monthly injections at baseline and Month 1; thereafter, the treatment interval was lengthened or shortened by 2 weeks (treatment intervals were ≥4 and ≤12 weeks). The primary objective was to demonstrate the non-inferiority of ranibizumab T&E to a monthly regimen, as assessed by the change in best-corrected VA (BCVA) from baseline to the end of study at one year. Key secondary objectives included assessment of change in central subfield retinal thickness (CSFT) from baseline to the end of study, treatment exposure, and safety.

Results :
Overall, 89.8% (T&E) and 90.2% (monthly) patients completed the study. Patient demographic and baseline characteristics were well balanced across treatment groups. The T&E regimen was non-inferior (p<0.001) to the monthly regimen with a least squares (LS) mean BCVA change of 6.2 versus 8.1 letters from baseline to the end of study, respectively. Mean change in CSFT from baseline to the end of study was −172.1 µm (T&E) and −173.3 µm (monthly). Fewer injections were required in patients receiving T&E (8.7) versus monthly (11.1) regimen. The most common ocular adverse events (AEs) were increase in intraocular pressure (T&E: 8.4%; monthly: 8.6%) and conjunctival hemorrhage (T&E: 4.3%; monthly: 5.8%). Ocular serious AEs (SAEs) were similar between groups (1.2% each). In general, ocular and non-ocular AEs and SAEs reported were comparable between groups.

Conclusions :
Ranibizumab 0.5 mg administered according to the T&E regimen was statistically non-inferior and clinically comparable to the monthly regimen in improving BCVA from baseline to the end of study with no new safety findings. Therefore, T&E treatment may provide comparable benefits to monthly treatment with fewer injections, thereby reducing treatment burden for patients, clinicians, and health care systems.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.